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Quality & Statistical Consulting for Medical Devices

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About me

DOUGLAS J. GERRARD, Ph.D.

Quality Executive, Statistician, Associate Professor, and Technical Author.

WORK EXPERIENCE

2002 – 2006             CYBERONICS, INC..

Senior Director, Product Performance

Accomplishments included development & growth of the Product Performance function, trend analysis and corporate statistical support.

 

1999 - 2002              GUIDANT CORPORATION, St. Paul, MInnesota

Scientific Fellow

Relocated to CRM Division in St. Paul to provide statistical oversight & statistical corporate training in  the analysis of technical issues.

 

1998 - 1999                  GUIDANT INTERMEDICS, INC., Angleton, Texas

                                       Vice President of Product Assurance

Retained by new owners, Guidant Corporation, to assist in the phase-out of Texas operations and the transfer of technologies to other facilities.

 

1995 – 1998            SULZER INTERMEDICS, INC., Angleton, Texas

Vice President of Product Assurance

Restructured the Quality System in conformance with the new FDA Quality System Regulation, passing the last three FDA audits and two TUV assessments.

 

1992 – 1995                   SIEMENS PACESETTER, INC., Sylmar, California

Senior Vice President of Quality Assurance

Headed the effort which cleared an FDA Warning Letter and resulted in PMA approval of the new primary manufacturing facility. Created a structured Quality System which led to EN 29001 certification by the European Notified Body.

 

1978 – 1992                   INTERMEDICS, INC., Freeport, Texas

Vice President of Product Assurance

Staffed, structured and guided the Product Assurance endeavor through a fourteen-year history of unexcelled product reliability within the industry.

 

1975 – 1978                    MEDTRONIC, INC., Minneapolis, Minnesota

Manager of Statistical Resources

Developed a statistically-based methodology for product performance reporting to the medical community, enabling the company to successfully manage a major field problem without the stigma of a Medical Device Safety Alert.

 

1968 – 1975        UNIVERSITY OF MINNESOTASt. Paul, Mn

Assistant Professor and Associate Professor

Taught courses in Forest Mensuration, Statistical Methods, Photogrammetry,  Research Methods and Design of Experiments

Supervised Ph.D. candidates in Forest Biometrics.

Conducted research and published papers in Statistical Ecology and Sampling Theory.

Provided consulting services to corporations.

 

1964 – 1968              MICHIGAN STATE UNIVERSITY, Department of Natural Resources, East Lansing, Michigan

Instructor and Assistant Professor

Prepared and taught courses in Forest Mensuration, Aerial Photographic Interpretation, Statistics and Forest Survey Methods.                     

Conducted and published doctoral thesis research.

 

1960 – 1964            UNIVERSITY OF TORONTO, Toronto, Canada

Lecturer, Departments of Civil Engineering and Forestry (1963 to 1964).

Instructor, Department of Applied Physics in the Faculty of Applied Science and Engineering

Taught courses to Civil Engineering and Forestry students in Analytical Photogrammetry and Statistical Methodology.

Conducted research in Photogrammetry and Statistics.

 

EDUCATION

1956 – 1960.         B. Sc. F.     University of Toronto

1961 – 1963.         M. Sc. F.    University of Toronto,

1965 – 1968.         Ph. D.        Michigan State University,

 

HONORARY SOCIETIES

Sigma Xi

Xi Sigma Pi

Phi Kappa Phi

douglasjgerrard@gmail.com